Laboratories designed for processing specimens have specialized machinery designed to measure different chemicals in a number of many biological samples and tests. The first biochemistry analyzers were used mainly for routine repetitive analyses. Over the years, they have been replaced by discrete working systems, which allow lower reagent consumption. These new instruments automate repetitive sample analysis steps which would otherwise have been done manually by a technician.
Automating the process used in biological samples is extremely advantageous especially in high throughput laboratories. In general, automation improves throughput, decreases error within and between experiments, and generates a report of the steps performed. As today's assays require smaller and smaller volumes, researchers require accuracy and CV data to be available for an increasing number of solvents. Nowadays, aim is to give a fast and reliable result with minimal human assistance.
Significant changes in this sector have been brought about as a result of the convergence of system-engineering, automation, and IT technology. Thus, the new technologies have enabled a better understanding of disease processes. The introduction of user-friendly automated devices has minimized human effort and increased the efficiency of diagnostic procedures.
In the last five years, the biochemistry industry has witnessed challenging and dynamic market conditions in terms of rising incidences of chronic diseases, increasing awareness of health and fitness, as well as major technological advancements. The market displays a growing preference for mergers and acquisitions to ensure the sustainability and growth of a company. Moreover, the pricing pressures and high competition in developed countries will compel companies to focus on emerging markets.
The Indian market for biochemistry instruments and reagents in 2015 is estimated at Rs.1060 crore, with reagents dominating with a 75 percent market share. The Indian market is steadily shifting to reagents sold for open systems, their share having gone up from 50 percent in 2014 to 55 percent in 2015.
In the analyzer segment, the market is moving toward automated systems, which constituted 57 percent of the market in 2015. Upgrading the laboratories to totally computerized fully automated systems has made a big difference in the bottom lines of many laboratories, by cutting down the cost of consumables and less requirement of qualified and trained technicians. These factors have prompted lab managers to go in for automation.
Bench-top lower-throughput analyzers are seeing maximum growth. These analyzers have been developed without compromising on efficiency and accuracy of the system.
Adenosine deaminase activity (ADA) infection markers for TB diagnosis are increasingly being used on the biochemistry platform.
Customers are placing a lot of weightage on the quality of service backup they receive. The emphasis is on getting complete solution from a single company.
High-end laboratories opt for automated integrated systems. Developing software programs has also allowed integration of various workflows of biochemistry analyzers for better control and operational efficiency.
The last couple of years have seen an increase not only in the number of hospital-attached laboratories but also an exponential growth in the diagnostic laboratories run by branded players in the Indian diagnostics market, including Super Religare Laboratories, Dr Lal Pathlabs, Quest Diagnostics, Thyrocare, and Metropolis. Entry of corporates into the pathology and laboratory segment with Tier-II and Tier-III expansions is leading to consolidation. The existing smaller labs are being taken over by corporate chains.
On The Growth Path
The diagnostic landscape in our country is highly fragmented. Still largely populated by unorganized players, approximately 10 percent is constituted by organized entities. The diagnostic lab business has traditionally been considered a high-margin, asset-intensive business. Thus, in an effort to match increasing demand, large players have endeavored to increase pan-India presence, by building national networks, over the last few years. Simultaneously, the market has witnessed continuous mushrooming of foreign players as well as standalone regional players. In addition, market leaders have expressed intent to penetrate foreign markets such as the Middle-East and Sri Lanka, whose economies are growing at par with India.
Growth has been pursued via a combination of the organic and inorganic route. Different approaches have included expansion via hub-and-spoke models, PPP initiatives, IPOs, and receiving funding from private equities.
Laboratory management in India is a super-specialized arena. The need of the hour is to make dedicated investments in terms of sophisticated analytical technologies, and skilled human resources, equipment, reagents; comply with stringent accreditation guidelines; and provide excellent customer service such as an exhaustive test menu, along with short and accurate reporting times. It is found that the cost of testing is inversely proportional to workload and directly proportional to overheads. Since a lab within a hospital is run as one of the many departments, it typically does not receive the necessary attention from hospital management. This results in high inventory and costs, pilferage, inadequate quality/service turn-around-time causing dissatisfaction amongst clinicians and patients.
In order to overcome these challenges, hospitals today are increasingly outsourcing lab management to external referral laboratories. This relatively new phenomenon is called Hospital Laboratory Management (HLM). HLM allows hospitals to offer the best diagnostic care to their patients, while maintaining focus on providing their core healthcare services. At the outset, the hospital saves both time and cost to set up a full-fledged, technologically advanced lab.
Modular Approach to Automation
The use of ELISAs for clinical testing within a laboratory is notably time- and personnel-consuming, with heavy resources used on manual interaction. Moving from ELISA technique to an automated biochemistry method for detection of the same analyte increases time- and personnel-efficiency considerably, and time and management efficiencies equal cost-effectiveness.
The significance of ensuring quality in testing practices and thus confidence in clinical results is also a key consideration for running automated biochemistry tests over manual ELISA testing techniques. The risk of error and contamination and, therefore, compromised clinical results, which is higher when running ELISA methods, will be greatly reduced through the alternative of biochemistry automation.
By transitioning analytes, historically available only on ELISA, to automated biochemistry methods, laboratories are able to expand their test offerings to patients and clinicians. As an example, within key cardiovascular testing, analyses such as H-FABP, 11dhTxB2, adiponectin, and sPLA2, being available in an automated biochemistry format, allow laboratories to expand their testing and test menu with ease.
Automated biochemistry analytes increase testing range, with little adjustment within the laboratory, allowing for detailed patient-testing profiles, without the manual restrictions placed by running ELISA techniques. Biochemistry is an established and stable market due to high levels of automation taking place in laboratories and as a result, demand for reagents and consumables is also growing. Over the last 20 years, the use of automation in clinical labs has progressed significantly, from the first random-access analyzer to total lab automation (TLA). Laboratories now desire complete solutions from a single provider, like closed system reagents with calibrators and controls, and viable software. This can help them in negotiation and also assure reliable service support. Many companies are launching their next-generation biochemistry automated integrated systems to suit the need of high-end laboratories. There is a demand for leases and reagent rental contracts, which minimize maintenance requirements.
Additionally, the biochemistry analyzer market is moving toward testing consolidation, which is creating demand for integrated systems with expanded capabilities, thereby securing the future of next-generation laboratory analyzers. Given the trends being observed among biochemistry labs today, automation will play an even larger role in the future, going beyond operational effectiveness to also positively impact clinical effectiveness and ultimately help improve patient outcomes.